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StarsHR has the following long-term contract opportunity available with our client in Greater Pittsburgh.
Embedded Software V&V Engineer
SUMMARY
This position will be responsible to perform software verification and validation of medical devices to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls.
DUTIES & RESPONSIBILITIES
Verification and Validation of software for complex system interactions in medical devices, including
Embedded software
Platform software
Operating system software
Development and execution of manual and/or automated software verification protocols, including:
Design and development of test scenarios
Authoring and review of test cases and protocols
Performing execution of test cases
Writing reports
Responsible for verification of the software platform of the medical device, including:
Sub-system testing
Performance and reliability
Safety and interoperability
Review and analysis of product and software requirements
Defect characterization and reporting. Assist in triaging of the defects.
Compliance with standard operating procedures for medical device development, including compliance with ISO 13485 and IEC 62304
Critical analysis of technical situations; identifies problems, and work with the cross-functional team in resolving the problems.
Collaborating within cross-functional teams across multiple geographies to convey problems, opportunities, solutions, and results in medical device R&D activities
Engaging in continuous improvement initiatives to establish Center of Excellence (CoE) in Software Assurance function.
REQUIREMENTS
Bachelors degree in engineering, preferably Computer, Electronics, or Biomedical
Minimum of 2 years of relevant work experience in software testing in medical device or in a regulated industry
Minimum of 1 years of relevant work experience in software test automation
Familiarity with Software Development Lifecycle processes, including Waterfall and Agile methodologies
Familiarity with C/C++, Python languages and test frameworks.
Understands impacts of hardware constraints on software environment.
Familiarity with ST microprocessor, FPGA, BLDC, peripheral device communication and embedded RTOS
Technical writing ability clear and concise writing easily understood by multiple audiences (testers, auditors, peers, etc.)
Preferences:
Experience designing and developing medical device software in a regulated environment while adhering to FDA Design Controls and software process guidelines for medical devices including ISO 13485 and IEC 62304.
This position is a long-term contract, potentially leading to perm. StarsHR can provide benefits while contracting through our company.
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